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A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone

Primary Purpose

Candidiasis, HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Methadone hydrochloride
Fluconazole
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis focused on measuring Methadone, Drug Interactions, Drug Therapy, Combination, Fluconazole, Antifungal Agents, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral therapy. Intermittent acetaminophen, aspirin, and ibuprofen. Patients must have: CD4 count >= 250 cells/mm3 within 3 months prior to study entry. Received a stable dose of methadone for a minimum of 30 days prior to study entry. Negative urine toxicology screen (except for methadone or methadone metabolites) within 14 days prior to study entry. Reasonably good health. Life expectancy of at least 6 months. Ability and willingness to comply with protocol requirements. NOTE: Patients will be recruited from the methadone maintenance treatment program currently administered by Addiction Research and Treatment Corporation. Enrollment of women is encouraged. NOTE: Patients who are currently enrolled in CPCRA treatment and prophylaxis trials are eligible for this study provided they have been permanently removed from study drug on the other protocol. Prior Medication: Required: Stable dose of methadone for a minimum of 30 days prior to study entry. Allowed: Prior antiretroviral therapy (dose should be stable for 14 days prior to study entry). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known sensitivity to azoles, methadone, and other opiate narcotics. Concurrent Medication: Excluded: Amiodarone. Anesthetics, general. Barbiturates. Carbamazepine. Cimetidine. Ciprofloxacin. Dexamethasone. Disulfiram. Erythromycin. Fluoroquinolones. Fluoxetine. Gestodene. Hydrochlorothiazide. Hypoglycemics, oral. Isoniazid. Itraconazole. Ketoconazole. Levomepromazine. MAO inhibitors. Methoxsalen. Nafcillin. Narcotic analgesics. Naringenin. Norethindrone. Omeprazole. Pentazocine. Phenothiazines. Phenytoin. Quinidine. Ranitidine. Rifabutin. Rifampin. Sedative hypnotics. Sulfaphenazole. Tranquilizers. Tricyclic antidepressants. Troleandomycin. Warfarin. Prior Medication: Excluded within 30 days prior to study entry: Ketoconazole, fluconazole, or itraconazole. Experimental drugs. Alcohol or illicit drug abuse.

Sites / Locations

  • Addiction Research and Treatment Corp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000788
Brief Title
A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone
Official Title
A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 1994 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
To evaluate the pharmacokinetics and safety of concomitant administration of methadone and fluconazole. Injection drug users constitute the second largest subset of the U.S. population at risk for HIV infection and AIDS-associated mortality. Narcotic addiction is often treated by use of methadone. Fluconazole has been shown to be highly effective in treating symptomatic mucosal candidiasis, but it is unknown whether fluconazole affects methadone metabolism, which could result in symptoms of methadone withdrawal or overdose in patients taking the drugs in combination.
Detailed Description
Injection drug users constitute the second largest subset of the U.S. population at risk for HIV infection and AIDS-associated mortality. Narcotic addiction is often treated by use of methadone. Fluconazole has been shown to be highly effective in treating symptomatic mucosal candidiasis, but it is unknown whether fluconazole affects methadone metabolism, which could result in symptoms of methadone withdrawal or overdose in patients taking the drugs in combination. Patients are randomized to receive methadone plus either fluconazole or placebo in clinic daily for 16 days. Study drugs are administered as close to 8 AM as possible. Patients must visit the Fort Greene clinic on study days 1, 2, 15, and 16; they may receive treatment at their home clinics on days 3 through 14.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, HIV Infections
Keywords
Methadone, Drug Interactions, Drug Therapy, Combination, Fluconazole, Antifungal Agents, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Methadone hydrochloride
Intervention Type
Drug
Intervention Name(s)
Fluconazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral therapy. Intermittent acetaminophen, aspirin, and ibuprofen. Patients must have: CD4 count >= 250 cells/mm3 within 3 months prior to study entry. Received a stable dose of methadone for a minimum of 30 days prior to study entry. Negative urine toxicology screen (except for methadone or methadone metabolites) within 14 days prior to study entry. Reasonably good health. Life expectancy of at least 6 months. Ability and willingness to comply with protocol requirements. NOTE: Patients will be recruited from the methadone maintenance treatment program currently administered by Addiction Research and Treatment Corporation. Enrollment of women is encouraged. NOTE: Patients who are currently enrolled in CPCRA treatment and prophylaxis trials are eligible for this study provided they have been permanently removed from study drug on the other protocol. Prior Medication: Required: Stable dose of methadone for a minimum of 30 days prior to study entry. Allowed: Prior antiretroviral therapy (dose should be stable for 14 days prior to study entry). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known sensitivity to azoles, methadone, and other opiate narcotics. Concurrent Medication: Excluded: Amiodarone. Anesthetics, general. Barbiturates. Carbamazepine. Cimetidine. Ciprofloxacin. Dexamethasone. Disulfiram. Erythromycin. Fluoroquinolones. Fluoxetine. Gestodene. Hydrochlorothiazide. Hypoglycemics, oral. Isoniazid. Itraconazole. Ketoconazole. Levomepromazine. MAO inhibitors. Methoxsalen. Nafcillin. Narcotic analgesics. Naringenin. Norethindrone. Omeprazole. Pentazocine. Phenothiazines. Phenytoin. Quinidine. Ranitidine. Rifabutin. Rifampin. Sedative hypnotics. Sulfaphenazole. Tranquilizers. Tricyclic antidepressants. Troleandomycin. Warfarin. Prior Medication: Excluded within 30 days prior to study entry: Ketoconazole, fluconazole, or itraconazole. Experimental drugs. Alcohol or illicit drug abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cobb M
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Letts A
Official's Role
Study Chair
Facility Information:
Facility Name
Addiction Research and Treatment Corp
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9663180
Citation
Cobb MN, Desai J, Brown LS Jr, Zannikos PN, Rainey PM. The effect of fluconazole on the clinical pharmacokinetics of methadone. Clin Pharmacol Ther. 1998 Jun;63(6):655-62. doi: 10.1016/S0009-9236(98)90089-3.
Results Reference
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A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone

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